Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders

Phase 2

Terminated

• Conditions: Autism Spectrum Disorder (ASD)
• Interventions: Drug: Omega-3 Fatty Acid

• Registration Number: NCT01248130
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The primary aim of this study is to examine the efficacy and tolerability of short-term omega-3 fatty acids monotherapy in youth with Autism Spectrum Disorders (ASD). The investigators hypothesize that Omega-3 fatty acids will be efficacious in improving the core and associated features of ASD in youth, and that Omega-3 fatty acids monotherapy will be safe and well tolerated by youth with ASD. The secondary aim of this study is to examine the neuropsychological effect of Omega-3 fatty acids monotherapy in youth with ASD. The investigators hypothesize that omega-3 fatty acids will be efficacious in improving cognitive functions in youth with ASD.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-23
• Study First Posted: 2010-11-25
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-09-15
• Results First Submitted QC: 2014-09-15
• Results First Posted: 2014-09-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3 Fatty Acid Treatment	Omega-3 Fatty Acid	-
Placebo (Sugar Pill)	Omega-3 Fatty Acid	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Social Responsiveness Scale (SRS) Total Raw Score	Pre-treatment - 12 weeks	The SRS is a 65-item rating scale completed by the participants parent or guardian. The scale measures the severity of autism spectrum symptoms as the occur in natural social settings. The total raw score is calculated by summing the 65 items. Total scores range from 0 to 195, where higher scores indicate greater severity. The outcome reported reflects the change from baseline (pre-treatment) in SRS Total raw score. When examining change from baseline, negative scores represent improvement (i.e., decrease in severity from baseline).

Secondary Outcome Measures

Name	Time	Method
Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) Improvement Scores	Pre-treatment - 12 weeks	The CGI-PDD Improvement scale is a clinician-rated assessment of the participant's improvement in symptoms compared to baseline. The CGI-PDD-I is rated on a scale of one (very much improved) to seven (very much worse) and values of zero (not assessed) are assigned to all participants at baseline. The outcome reported reflects the change in improvement score from baseline, where lower scores indicate greater improvement compared to baseline.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States